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Further study details as provided by Melissa Gilliam, University of Chicago:

Primary Outcome Measures:

Retention Rate [ Time Frame: 6 months ]

Percentage of participants who completed the final visit (i.e., not subject to early termination or loss to follow-up)

Secondary Outcome Measures:

Heavy Bleeding Rates [ Time Frame: 6 months ]

Rates of participants experiencing heavy bleeding among teens randomized to the LNG-IUS or Copper T 380A.

Pregnancy Rates [ Time Frame: 6 months ]

Proportion of subjects who became pregnant within 6 months of IUD insertion

Expulsion Rates [ Time Frame: 6 months ]

Rates of partial or complete expulsion for teens randomized to the LNG-IUS or Copper T 380A. Patients experiencing partial expulsion had IUDs visible on speculum exam. Complete expulsion is characterized by complete evacuation of the IUD.

Device Satisfaction Rates [ Time Frame: 6 months ]

Satisfaction rate is the proportion of subjects who report being "happy" or "very happy" with their assigned intrauterine contraceptive method on the date of their 6 month study visit.

Participants in this arm had a Levonorgestrel-releasing intrauterine device (LNG-IUS), also known as the Mirena IUD, inserted within the first 5 days of the adolescent's menstrual cycle, at least 7 weeks after a vaginal or cesarean delivery or second-trimester abortion or at least 3 weeks after a first-trimester abortion. For participants who had used depot-medroxyprogesterone acetate, insertions occurred at least 6 months after the participant's last injection. Participants were blinded to the device type; however, investigators and research assistants were not.

Device: Levonorgestrel-releasing intrauterine device (LNG-IUS)

Teens are randomly assigned to receive the LNG-IUS after completing a screening visit.

Other Name: Mirena IUD

Active Comparator: Paragard IUD [Copper T380A]

Participants in this arm had a Copper T380A intrauterine device (CuT380A), also known as the Paragard IUD, inserted within the first 5 days of the adolescent's menstrual cycle, at least 7 weeks after a vaginal or cesarean delivery or second-trimester abortion or at least 3 weeks after a first-trimester abortion. For participants who had used depot-medroxyprogesterone acetate, insertions occurred at least 6 months after the participant's last injection. Participants were blinded to the device type; however, investigators and research assistants were not.

Device: Copper T380A intrauterine device (CuT380A)

Teens are randomly assigned to Copper T380 after the screening visit

Other Name: Paraguard IUD

Detailed Description:

Teenagers have the highest percentage of unintended pregnancies, and often struggle to comply with daily methods of contraception. The intrauterine device (IUD) provides safe, long-term protection and rates highly for patient satisfaction. It also does not require repeat prescriptions or clinic visits, making it a potentially attractive method among teens. However, in adolescent populations, there is both a lack of information about the IUD, as well as few studies that have examined the use of these devices. This study will examine whether a larger scale study on this topic is feasible. IT will address the feasibility of recruiting, consenting, screening, enrolling, randomizing, and retaining adolescents randomized to the LNG-IUS or Copper T 380a.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

14 Years to 18 Years (Child, Adult)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Healthy, sexually active females age 14 to 18 who:

Are interested in long term, reversible contraception

Have regular menstrual cycles (21-35 days)

Are not planning a pregnancy within the next 6 months

Exclusion Criteria:

Sexually active females age over the age of 18 or who:

Are not interested in long term, reversible contraception

Do not have regular menstrual cycles (21-35 days)

Are planning a pregnancy within the next 6 months

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653159